EUDAMED last updated this device on Apr 13, 2022

002

805571232ENFPHYSIOGJ

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fast Therapies srl
UDI-DI code: 08055712320009
Reference / catalog number: 002

002 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Fast Therapies srl. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

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Date of registration
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EUDAMED last updated this device on Apr 13, 2022

002

805571232ENFPHYSIOGJ

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fast Therapies srl
UDI-DI code: 08055712320009
Reference / catalog number: 002

View device family (Basic UDI)

Device identification

Trade name: not provided
UDI-DI code: 08055712320009
Basic UDI-DI: 805571232ENFPHYSIOGJ
Reference / catalog number: 002
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Dispositivo Medico
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08055712320009

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z120601ELECTROTHERAPY EQUIPMENT (INCLUDED TENS)

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Italy; available across 32 countries total.

Country	On market since	Until
ItalyPrimary placement	Jan 1, 2010	Dec 31, 2039
Austria	Jan 1, 2010	Dec 31, 2039
Belgium	Jan 1, 2010	Dec 31, 2039
Bulgaria	Jan 1, 2010	Dec 31, 2039
Cyprus	Jan 1, 2010	Dec 31, 2039
Czechia	Jan 1, 2010	Dec 31, 2039
Germany	Jan 1, 2010	Dec 31, 2039
Denmark	Jan 1, 2010	Dec 31, 2039
Estonia	Jan 1, 2010	Dec 31, 2039
EL	Jan 1, 2010	Dec 31, 2039
Spain	Jan 1, 2010	Dec 31, 2039
Finland	Jan 1, 2010	Dec 31, 2039
France	Jan 1, 2010	Dec 31, 2039
Croatia	Jan 1, 2010	Dec 31, 2039
Hungary	Jan 1, 2010	Dec 31, 2039
Ireland	Jan 1, 2010	Dec 31, 2039
Iceland	Jan 1, 2010	Dec 31, 2039
Liechtenstein	Jan 1, 2010	Dec 31, 2039
Lithuania	Jan 1, 2010	Dec 31, 2039
Luxembourg	Jan 1, 2010	Dec 31, 2039
Latvia	Jan 1, 2010	Dec 31, 2039
Malta	Jan 1, 2010	Dec 31, 2039
Netherlands	Jan 1, 2010	Dec 31, 2039
Norway	Jan 1, 2010	Dec 31, 2039
Poland	Jan 1, 2010	Dec 31, 2039
Portugal	Jan 1, 2010	Dec 31, 2039
Romania	Jan 1, 2010	Dec 31, 2039
Sweden	Jan 1, 2010	Dec 31, 2039
Slovenia	Jan 1, 2010	Dec 31, 2039
Slovakia	Jan 1, 2010	Dec 31, 2039
Türkiye	Jan 1, 2010	Dec 31, 2039
XI	Jan 1, 2010	Dec 31, 2039

Device identification

Trade name: not provided
UDI-DI code: 08055712320009
Basic UDI-DI: 805571232ENFPHYSIOGJ
Reference / catalog number: 002
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Dispositivo Medico
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

Manufacturer information

Organization name: Fast Therapies srl
SRN: IT-MF-000022192
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08055712320009

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z120601ELECTROTHERAPY EQUIPMENT (INCLUDED TENS)

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

Certificates

Certificate health across this manufacturer's portfolio.

IT349045Issued
Quality management systemNotified body: 1370Expiry: Jan 18, 2030

Legacy certificates

Certificate number: IT349045
Type: Quality management system
Notified body: BUREAU VERITAS ITALIA S.P.A. (1370)
Validity: Jan 19, 2026 → Jan 18, 2030

Certificates covering this device

IT349045Issued
Quality management systemNotified body: 1370Expiry: Jan 18, 2030

All products by Fast Therapies srl

Market distribution

Primary placement in Italy; available across 32 countries total.

Country	On market since	Until
ItalyPrimary placement	Jan 1, 2010	Dec 31, 2039
Austria	Jan 1, 2010	Dec 31, 2039
Belgium	Jan 1, 2010	Dec 31, 2039
Bulgaria	Jan 1, 2010	Dec 31, 2039
Cyprus	Jan 1, 2010	Dec 31, 2039
Czechia	Jan 1, 2010	Dec 31, 2039
Germany	Jan 1, 2010	Dec 31, 2039
Denmark	Jan 1, 2010	Dec 31, 2039
Estonia	Jan 1, 2010	Dec 31, 2039
EL	Jan 1, 2010	Dec 31, 2039
Spain	Jan 1, 2010	Dec 31, 2039
Finland	Jan 1, 2010	Dec 31, 2039
France	Jan 1, 2010	Dec 31, 2039
Croatia	Jan 1, 2010	Dec 31, 2039
Hungary	Jan 1, 2010	Dec 31, 2039
Ireland	Jan 1, 2010	Dec 31, 2039
Iceland	Jan 1, 2010	Dec 31, 2039
Liechtenstein	Jan 1, 2010	Dec 31, 2039
Lithuania	Jan 1, 2010	Dec 31, 2039
Luxembourg	Jan 1, 2010	Dec 31, 2039
Latvia	Jan 1, 2010	Dec 31, 2039
Malta	Jan 1, 2010	Dec 31, 2039
Netherlands	Jan 1, 2010	Dec 31, 2039
Norway	Jan 1, 2010	Dec 31, 2039
Poland	Jan 1, 2010	Dec 31, 2039
Portugal	Jan 1, 2010	Dec 31, 2039
Romania	Jan 1, 2010	Dec 31, 2039
Sweden	Jan 1, 2010	Dec 31, 2039
Slovenia	Jan 1, 2010	Dec 31, 2039
Slovakia	Jan 1, 2010	Dec 31, 2039
Türkiye	Jan 1, 2010	Dec 31, 2039
XI	Jan 1, 2010	Dec 31, 2039

002

002

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Substances

Regulatory

Lifecycle

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Substances

Regulatory

Lifecycle

Certificates

Legacy certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Legacy certificates

Certificates covering this device

Related devices